L40
Conditions
Interventions
Group 1: A total of 200 patients are planned to be included, consisting primarily of dermatologically managed patients with psoriasis vulgaris and rheumatologically managed patients with psoriatic art
Sponsors
Universitätsklinikum Würzburg, Dermatologologie, Venerologie und Allergologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Presence of moderate to severe psoriasis with or without psoriatic arthritis Capacity to provide informed consent, age over 18 years, possession of a smartphone
Exclusion criteria
Exclusion criteria: Lack of capacity to provide informed consent Age under 18 years No possession of a smartphone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study objectives: Prediction of new disease flares through AI- and AutoML-based image, movement, and data analyses a. Creation of a digital dataset of patients with psoriasis and psoriatic arthritis b. Training of machine learning algorithms with the above-mentioned digital dataset to generate predictions and optimize processes c. Identification of non-linear relationships between patient disease data and disease course or treatment response Analysis of current psoriasis and psoriatic arthritis management within the framework of app usage and the interdisciplinary outpatient clinic a. Assessment of therapy compliance and treatment satisfaction (measured using a compliance questionnaire and a visual analogue scale in the app) b. Evaluation of the Patient Benefit Index (PBI) Analysis of treatment outcomes and patient care for psoriasis and psoriatic arthritis within the framework of app usage and the interdisciplinary outpatient clinic a. Extent of skin and joint involvement b. Itch c. Pain d. Quality of life e. Psychological well-being of patients i. measured using patient-reported outcome scores (see below) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the app and the interdisciplinary outpatient clinic by patients using free-text feedback and multiple-choice questions. Provision of a decision basis regarding the feasibility of a future subsequent clinical trial aimed at obtaining approval of the app as a Class I medical device. a. This is a pure feasibility study, within which the following aspects will be assessed: i. organizational implementation ii. technical feasibility iii. practical applicability iv. resources and availability of medical staff for patient care via the app | — |
Countries
Germany
Contacts
Public ContactAstrid Schmieder
Universitätklinikum Würzburg, Dermatologie
Outcome results
None listed